Merck and Pfizer announced that the Food and Drug Administration (FDA) has approved Steglatro (ertugliflozin) tablets and Steglujan (ertugliflozin and sitagliptin) tablets for use in adults with type 2 diabetes.
Specifically, Steglatro is indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, and Steglujan is indicated as adjunct when treatment with both ertugliflozin and sitagliptin are appropriate. Ertugliflozin is an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor and sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor.
The new approvals were based on data from seven Phase 3 studies involving approximately 4800 patients. Steglatro was evaluated as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type 2 diabetes and moderate renal impairment. The data showed significant A1c reductions when Steglatro was used alone or with sitagliptin.
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In VERTIS SITA2, a 26-week, double-blind, placebo-controlled study (n=463), Steglatro was compared to placebo in patients with inadequately controlled type 2 diabetes taking background metformin and sitagliptin. Significant additional A1c reductions on top of metformin plus sitagliptin were seen with 0.7% and 0.8% reductions, respectively, for the 5 mg and 15 mg doses vs 0.2% reduction for placebo (P <.001).
The FDA has also approved Segluromet (ertugliflozin and metformin HCl), which is indicated as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin.
Steglatro will be available as 5 mg and 15 mg strength tablets. Steglujan will be available as 5 mg/100 mg and 15 mg/100 mg strength tablets. Segluromet will be available as 2.5 mg/500 mg, 2.5 mg/1000 mg, 7.5 mg/500 mg, and 7.5 mg/1000 mg strength tablets. Steglatro and Steglujan are expected to be available in January 2018 while Segluromet is expected to be available February 2018.
Reference
FDA approves SGLT2 inhibitor STEGLATRO™ (ertugliflozin) and fixed-dose combination STEGLUJAN™ (ertugliflozin and sitagliptin) for adults with type 2 diabetes [press release]. Kenilworth, NJ & New York; Merck: December 22, 2017. Accessed January 3, 2018.
This article originally appeared on MPR
